Direct Links to important GMP Sterile & Aseptic Processing Guidelines

PIC/S Validation of Aseptic Processing (PI 007-6) 2011

Detailed recommendations on the validation of aseptic processes, relating to different drug formulations including statistic limits. The document refers to ISO 13408-1.

FDA Guidance for Industry: Sterile Drug Products Produced By Aseptic Processing - Current Good Manufacturing Practice, September 2004

These FDA guidelines reveal certain methods and procedures which must be taken account of in the aseptic manufacture of sterile medicinal products in order to comply with the CGMP requirements.

EU GMP Annex 1: Manufacture of Sterile Medicinal Products

Supplementary guidelines to the EC-GMP Guide with specific requirements for the manufacture of sterile medicinal products.

PIC/S Recommendations on Sterility Testing (PI 0012-3) Sept 2007

This document provides guidance for GMP inspectors in order to promote a consistent and thorough approach to the inspection of all aspects of sterilty testing.

EU GMP Annex 17: Real Time Release Testing and Parametric Release

Annexes to the EC GMP Guideline indicating possibilities of parametric release for terminally-sterilised products.

FDA Guide to Inspections of Sterile Drug Substance Manufacturers, July 1994

These guidelines of ORA within FDA are not addressed to the industry but to the FDA inspectors. The Guides to Inspection are, however, a useful aid. Here you will find guidelines for the inspection of manufacturers of sterile active ingredients. For sterile active ingredients the general active ingredients guidelines, which are supplemented here by specific requirements for sterile active ingredients, also apply.

FDA Sterilization Process Validation, January 1993

These FDA guidelines for the validation of sterilization methods were compiled by the Center for Veterinary Medicine and by the Center for Drug Evaluation and Research. They contain recommendations as to which information about the validation of the sterilization methods used must be communicated to FDA when applying for marketing authorization for human and veterinary medicinal products.

FDA Guidance for Industry: SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In-Vitro Release Testing and In Vivo Bioequivalence Documentation

SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In-Vitro Release Testing and In Vivo Bioequivalence

Japanese Guidance on the Manufacture of Sterile Pharmaceutical Products by Aseptic Processong

Japanese requirements on aseptic processing

PIC/S Validation-Master Plan, IQ, OQ, non-sterile Process Validation, Cleaning Validation (PI 006-3) Sept 2007

This document comprises individual Recommendations on four topics relating to Equipment Qualification and Process Validation in pharmaceutical manufacture, as follows: Validation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning Validation The four Recommendations comprising this document define general principles pertaining to each of the topics.

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